Dengue FeverPhase 2NCT01064141
A Study of Dengue Vaccine in Healthy Toddlers Aged 12 to 15 Months in the Philippines
A Phase 2 study testing Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus, OKAVAX®:Attenuated live varicella-zoster virus and AVAXIM® 80U: Hepatitis A virus Vaccines and Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus and Childhood vaccines in people with Dengue Fever and Dengue Hemorrhagic Fever, run by Sanofi at 1 site in Philippines.
Trial summary
The purpose of this study is to investigate the potential for co-administration of the first dose of CYD Dengue vaccine with childhood vaccination. Primary Objectives: To describe the safety of CYD Dengue vaccine after each dose; first dose given alone or coadministered with childhood vaccines. Read more about this study
- Who is it for?
- Ages 12 to 15 monthsHealthy volunteers can take part
- Conditions the study is for
- Dengue Fever, Dengue Hemorrhagic Fever
- What is being tested?
- Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus, OKAVAX®:Attenuated live varicella-zoster virus and AVAXIM® 80U: Hepatitis A virus Vaccines and Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus and Childhood vaccines
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 sitePhilippines
- Study dates
- Jan 2010to Nov 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 15 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Toddler in good health based on medical history and medical examination
- Toddler aged 12 to 15 months on the day of inclusion
- Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg
- Provision of informed consent form signed by the parent(s) or other legally acceptable representative (and by an independent witness if required by local regulations)
- Participant and parent/delegate able to attend all scheduled visits and comply with all trial procedures
- Completion of previous vaccination program according to the national immunization schedule, except for measles
Who cannot join
- Family members from the Investigator or from the staff involved in the trial
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- History of central nervous system disorder or disease, including seizures
- History of varicella, measles, mumps, rubella and hepatitis A; confirmed either clinically, serologically, or microbiologically
- Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion
Show all 19Show fewer
- Previous vaccination against measles-mumps-rubella, hepatitis A or varicella
- Previous vaccination against flavivirus diseases
- Known systemic hypersensitivity to any of the components of the vaccines, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
- Planned participation in another clinical trial during the present trial period
- Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination
- Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
- Planned receipt of any vaccine in the 4 weeks following the first trial vaccination
- Human immunodeficiency virus (HIV) seropositivity in the blood sample taken at screening
- Clinically significant laboratory abnormalities, as judged by the Investigator, in blood sample taken at screening
- Temporary exclusions: vaccination postponed until the condition is resolved:
- Febrile illness (temperature ≥ 38°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment
- Receipt of oral or injected antibiotic therapy within 72 hours prior to the vaccination visit
- Any vaccination received in the 4 weeks preceding vaccination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunogenicity and Safety of CYD Dengue Vaccine in Healthy Toddlers Aged 12 to 15 Months in the Philippines
The purpose of this study is to investigate the potential for co-administration of the first dose of CYD Dengue vaccine with childhood vaccination.
Primary Objectives:
- To describe the safety of CYD Dengue vaccine after each dose; first dose given alone or coadministered with childhood vaccines.
Secondary Objectives:
- To describe the immunogenicity of CYD Dengue vaccine after each dose; first dose given alone or co-administered with childhood vaccines.
Read the detailed description
Participants will be enrolled in a 3-step enrollment and randomized to 1 of 4 treatment groups. Groups 1 and 2 will receive 5 vaccinations, and Groups 3 and 4 will received 6 vaccinations (childhood vaccines or placebo co-administered with the first dose of CYD Dengue vaccine in 2 separate arms). All toddlers will receive a pentavalent acellular pertussis combination vaccine or Combo (PENTAXIM®), planned approximately 10 months after enrollment.
- Conditions
- Dengue Fever, Dengue Hemorrhagic Fever
- Being tested
- Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus, OKAVAX®:Attenuated live varicella-zoster virus and AVAXIM® 80U: Hepatitis A virus Vaccines, Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus and Childhood vaccines, Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus and NaCl (Placebo)
- Keywords
- Dengue Fever, Dengue Hemorrhagic Fever, CYD Dengue Vaccine, Toddlers
- Medical subject headings
- Dengue, Severe Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virusBiological
Also called CYD Dengue Vaccine
0.5 mL, Subcutaneous
OKAVAX®:Attenuated live varicella-zoster virus and AVAXIM® 80U: Hepatitis A virus VaccinesBiological
Also called OKAVAX®, AVAXIM® 80U
0.5 mL, Subcutaneous and 0.5 mL, Intravascular
Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus and Childhood vaccinesBiological
Also called CYD Dengue Vaccine, TRIMOVAX®
0.5 mL, Subcutaneous and 0.5 mL, Subcutaneous
Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus and NaCl (Placebo)Biological
Also called CYD Dengue Vaccine, NaCl 0.9% (Placebo)
0.5 mL Subcutaneous and 0.5 mL Subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Dengue Vaccine Group | Experimental | Participants will receive CYD Dengue vaccine as Visits 1 and 2. Receives: Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus |
| Group 2: Control Group | Active comparator | Participants will receive Control Vaccines. (Varicella at Visit 1 and Hepatitis A at Visit 2) Receives: Biological: OKAVAX®:Attenuated live varicella-zoster virus and AVAXIM® 80U: Hepatitis A virus Vaccines |
| Group 3: Co-administration Group | Experimental | Participants will receive CYD Dengue vaccine and childhood vaccines at Visit 1 and CYD Dengue vaccine at Visit 2. Receives: Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus and Childhood vaccines |
| Group 4: Sequential Administration Group | Experimental | Participants will receive CYD Dengue vaccine and a Placebo vaccine at Visit 1 and CYD Dengue vaccine at Visit 2. Receives: Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus and NaCl (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To provide information concerning the safety in terms of solicited and unsolicited adverse events after primary administration of CYD Dengue vaccine.
Measured: 28 days after each Dengue vaccination and entire study duration
Secondary outcomes (2)
To provide information concerning the immunogenicity of CYD Dengue vaccine after each dose of primary vaccination.
Measured: Day 28 after each Dengue vaccination
To provide information concerning the immunogenicity of childhood vaccines after primary vaccination.
Measured: Day 28 after post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionSep 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dengue FeverStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01064141
- Sponsor's protocol ID
- CYD08
- Other IDs
- UTN: U1111-1111-5855
- Status last verified
- Feb 2013
- First submitted
- 5 Feb 2010
- Last updated
- 6 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of CYD Dengue Vaccine in Healthy Toddlers Aged 12 to 15 Months in the Philippines
- ClinicalTrials.gov ID
- NCT01064141
- Acronym / sponsor ID
- CYD08
- Conditions
- Dengue Fever, Dengue Hemorrhagic Fever
- Keywords
- Dengue Fever, Dengue Hemorrhagic Fever, CYD Dengue Vaccine, Toddlers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 8 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the potential for co-administration of the first dose of CYD Dengue vaccine with childhood vaccination.
Primary Objectives:
- To describe the safety of CYD Dengue vaccine after each dose; first dose given alone or coadministered with childhood vaccines.
Secondary Objectives:
- To describe the immunogenicity of CYD Dengue vaccine after each dose; first dose given alone or co-administered with childhood vaccines.
Detailed description
Participants will be enrolled in a 3-step enrollment and randomized to 1 of 4 treatment groups. Groups 1 and 2 will receive 5 vaccinations, and Groups 3 and 4 will received 6 vaccinations (childhood vaccines or placebo co-administered with the first dose of CYD Dengue vaccine in 2 separate arms). All toddlers will receive a pentavalent acellular pertussis combination vaccine or Combo (PENTAXIM®), planned approximately 10 months after enrollment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: Dengue Vaccine Group | Experimental | Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virusParticipants will receive CYD Dengue vaccine as Visits 1 and 2. |
| Group 2: Control Group | Active comparator | Biological: OKAVAX®:Attenuated live varicella-zoster virus and AVAXIM® 80U: Hepatitis A virus VaccinesParticipants will receive Control Vaccines. (Varicella at Visit 1 and Hepatitis A at Visit 2) |
| Group 3: Co-administration Group | Experimental | Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus and Childhood vaccinesParticipants will receive CYD Dengue vaccine and childhood vaccines at Visit 1 and CYD Dengue vaccine at Visit 2. |
| Group 4: Sequential Administration Group | Experimental | Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus and NaCl (Placebo)Participants will receive CYD Dengue vaccine and a Placebo vaccine at Visit 1 and CYD Dengue vaccine at Visit 2. |
Who may qualify
- Ages
- 12 to 15 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Toddler in good health based on medical history and medical examination
- Toddler aged 12 to 15 months on the day of inclusion
- Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg
- Provision of informed consent form signed by the parent(s) or other legally acceptable representative (and by an independent witness if required by local regulations)
- Participant and parent/delegate able to attend all scheduled visits and comply with all trial procedures
Key exclusion criteria (19 listed)
- Family members from the Investigator or from the staff involved in the trial
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- History of central nervous system disorder or disease, including seizures
- History of varicella, measles, mumps, rubella and hepatitis A; confirmed either clinically, serologically, or microbiologically
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virusAlso: CYD Dengue Vaccine0.5 mL, Subcutaneous | Biological | Group 1: Dengue Vaccine Group |
| OKAVAX®:Attenuated live varicella-zoster virus and AVAXIM® 80U: Hepatitis A virus VaccinesAlso: OKAVAX®, AVAXIM® 80U0.5 mL, Subcutaneous and 0.5 mL, Intravascular | Biological | Group 2: Control Group |
| Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus and Childhood vaccinesAlso: CYD Dengue Vaccine, TRIMOVAX®0.5 mL, Subcutaneous and 0.5 mL, Subcutaneous | Biological | Group 3: Co-administration Group |
| Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus and NaCl (Placebo)Also: CYD Dengue Vaccine, NaCl 0.9% (Placebo)0.5 mL Subcutaneous and 0.5 mL Subcutaneous | Biological | Group 4: Sequential Administration Group |
Primary outcome
To provide information concerning the safety in terms of solicited and unsolicited adverse events after primary administration of CYD Dengue vaccine.
Time frame: 28 days after each Dengue vaccination and entire study duration
2 secondary outcomes
To provide information concerning the immunogenicity of CYD Dengue vaccine after each dose of primary vaccination.
Time frame: Day 28 after each Dengue vaccination
To provide information concerning the immunogenicity of childhood vaccines after primary vaccination.
Time frame: Day 28 after post-vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2013.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Sanofi Pasteur Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus, OKAVAX®:Attenuated live varicella-zoster virus and AVAXIM® 80U: Hepatitis A virus Vaccines and Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus and Childhood vaccines in people with Dengue Fever and Dengue Hemorrhagic Fever, run by Sanofi at 1 site in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To provide information concerning the safety in terms of solicited and unsolicited adverse events after primary administration of CYD Dengue vaccine. (time frame: 28 days after each Dengue vaccination and entire study duration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2013.